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Press Clipping / Nov 12, 2018

Hovione expands production capacity of oral dosage forms

in-PharmaTechnologist, November 12, 2018

The Portuguese CDMO has announced plans to improve production capacity by bringing in commercial scale equipment for blending, tabletting and coating.

The new equipment will work alongside existing smaller scale equipment to offer customers a "one site shop" to take products through the development process to market.

The contract development and manufacturing organisation (CDMO), headquartered in Loures, Portugal, began its expansion project in 2016 and stated that this will continue for the next five years.

The first step of this process began with moving its development services to a 7,000 m2 facility in Lisbon, where the company handles potent and highly potent compounds.

Frédéric Kahn, VP of marketing and sales at Hovione, explained, "Our customers now see drug product manufacturing at the site where they produce their drug product intermediate as a natural extension of the range of value-added services they expect from us. They want to keep their product in the same capable hands."

The CDMO announced that the capacity expansion would be completed alongside the qualification of its continuous tabletting line, which it expects to be completed by the end of 2018.

Hovione completed its continuous manufacturing installation at its New Jersey, US, site at the end of last year - after doubling the size of the development and manufacturing operations.

 

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Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

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